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Senior Clinical Research Associate
@Eikon Therapeutics
[Hiring] Senior Clinical Research Associate @Eikon Therapeutics
Apr 03, 2025 - Eikon Therapeutics is hiring a remote Senior Clinical Research Associate. đź’¸ Salary: $130,000 to $142,500. đź“ŤLocation: USA.
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Role Description
We are seeking a highly experienced, collaborative, and detail-oriented Senior Clinical Research Associate (CRA). The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) team, Functional Service Provider (FSP) CRAs and internal study teams across therapeutic areas to monitor, qualify and initiate sites, ensure data quality and manage site relationships to support study deliverables.
About You
- Significant monitoring experience with clinical trial sites.
- Adept at developing and maintaining relationships to secure compliance and study deliverables.
- Experience independently monitoring with strong knowledge of Good Clinical Practice and clinical trial regulations.
- Strong collaborator across clinical functional areas with the ability to creatively and independently resolve complex issues.
- Ability to develop and maintain positive site relationships while ensuring optimal trial conduct and quality.
What You’ll Do
- Develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate study milestones.
- Promote awareness of Eikon’s clinical pipeline and programs to trial sites, investigators, and networks.
- Execute remote or on-site qualification of sites for Eikon trials and facilitate site selection.
- Schedule and conduct Site Initiation, Interim Monitoring and Close-Out visits as needed for multiple oncology trials.
- Regularly review site and monitoring Key Risk Indicator metrics to detect issues and ensure prompt resolution.
- Train and re-train sites on GCP, the protocol, vendor processes and study-specific documents.
- Perform consistent site management and resolve monitoring quality issues; develop/ensure implementation of site Corrective and Preventive Action (CAPA) Plans.
- Ensure sites are inspection-ready and support Eikon during site inspections.
- Effectively utilize the Clinical Trial Management System (CTMS) and Trial Master File (TMF) for accurate site data.
- Independently draft, review or contribute to the development of a Clinical Site Monitoring Plan as needed.
- Contribute to monitoring process improvement initiatives by reviewing and/or developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
- Improve site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS and Electronic Data Capture (EDC).
- Establish and foster effective relationships with internal and external stakeholders.
Qualifications
- Completion of a bachelor’s degree (scientific or clinical field is preferred) is required; an advanced degree is preferred.
- 6+ years monitoring Oncology (solid tumor) trials (with a minimum of 3 years monitoring phase I Oncology) is required.
- Previous experience independently conducting on-site and remote monitoring visits is required.
- Experience utilizing Veeva CTMS, CDMS (EDC), RTSM (IRT) and TMF (a minimum of 2 years) is required.
- Experience supporting site and/or sponsor inspections is preferred.
- Site travel of approximately 50-75% is required; this travel percentage could increase to meet urgent business needs.
Benefits
- 401k plan with company matching.
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%).
- Mental health and wellness benefits.
- Weeklong summer and winter holiday shutdowns.
- Generous paid time off and holiday policies.
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies.
- Enhanced parental leave benefit.
- Daily subsidized lunch program when on-site.
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| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
đź’¸
$130,000 to $142,500
|
Remote
Location
USA
|
|
Job Type
unspecified
|
Posted
Apr 03, 2025
|
️
| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
